510(k) Report

Devices descending from K153022

21 later devices reach Philips IntelliSpace Cardiovascular through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251215Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V.20250—
+1K1537363mensio WorkstationPie Medical Imaging BV2016191
+2K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+2K2503303mensio WorkstationPie Medical Imaging BV202501
+2K242500LaralabLaralab GmbH20250—
+2K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+2K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+2K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+2K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+2K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+2K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+2K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+2K190874Materialise Mimics EnlightMaterialise NV20192—
+3K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+3K260300WatchMate SoftwareAnumana, Inc.20260—
+3K252195ARTICOR plannerArtiness S.R.L20260—
+3K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+3K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+3K242166TribusConnectTribusmed Beheer BV20250—
+3K233217Mimics Cardiac PlannerMaterialise NV20240—
+4K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—